WHO IS FRANK?

Frank has had diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, data standards, benefit/risk, real world evidence, cardiovascular research, and, most recently, safety and pharmacovigilance.  He has been a leader in the scientific community in promoting data disclosure and transparency in clinical research.

Frank is a full-time Professor of Biostatistics and Bioinformatics at Duke Clinical Research Institute and Managing Partner of HunterRockhold, Inc., which provides strategic consulting to Industry, Government, and Academia in the areas of clinical trials, pharmacovigilance, data disclosure, and transparency.

His 40-year career includes senior research positions at Lilly, Merck, and GlaxoSmithKline, where he recently retired as Senior Vice President of Global Clinical Safety and Pharmacovigilance.  He has held faculty appointments at 6 different universities. Frank served for 9 years on the board of directors of the non-profit CDISC, most recently as Chairman, and is past president of the Society for Clinical Trials. He is a member of the PCORI Clinical Trials Advisory Panel and is on the board of the Frontier Science and Technology Research Foundation.

Frank holds a BA in Statistics from The University of Connecticut, an ScM in Biostatistics from The Johns Hopkins University, and a PhD in Biostatistics from The Medical College of Virginia. Frank is a Fellow of both the American Statistical Association and the Society for Clinical Trials and an Accredited Professional Statistician, PStat®.   He is widely published in major scientific journals across a wide variety of research topics.

ACADEMIC EXPERIENCE

  • Full Professor of Biostatistics and Bioinformatics, Duke University School of Medicine (current)
  • Affiliate Professor of Biostatistics, Virginia Commonwealth University Medical Center (current)
  • Duke University School of Medicine, Adjunct Professor of Biostatistics and Bioinformatics
  • University of Pennsylvania, Adjunct Scholar, Epidemiology and Biostatistics
  • Penn State College of Medicine, Adjunct Professor, Department of Public Health Sciences
  • Medical College of Virginia/Virginia Commonwealth University, Graduate Faculty, Department of Biostatistics
  • Indiana University School of Business Administration, Lecturer, Department of Quantitative Business Analysis
  • Butler University School of Business Administration, Lecturer, Department of Management Science

INDUSTRY EXPERIENCE

  • Chief Safety Officer and Head of Global Clinical Safety and Pharmacovigilance
  • Chaired Global Safety Board and internal Data Monitoring Committee
  • Head of Cardiovascular Research
  • Head of Biostatistics, Epidemiology and Health Informatics with groups in US, Asia and Europe and a staff of 1500
  • Head of Clinical Operations
  • Worked on more than 100 new molecular entities in every therapeutic area including vaccines and consumer health
  • Led the development of the world’s first protease inhibitor for AIDS from clinical trials to market.

ACADEMIC QUALIFICATIONS

  • PhD in Biostatistics, Virginia Commonwealth University
  • ScM In Biostatistics, Johns Hopkins University
  • B.A. in Statistics, University of Connecticut
  • ACCREDITED PROFESSIONAL STATISTICAN™, PStat® , 2012
  • More than 75 Publications in peer reviewed scientific journals (see selected publications)
  • More than 75 presentations at Scientific Symposia

HONORS & AWARDS

  • Fellow, American Statistical Association.
  • Fellow, Society for Clinical Trials
  • ACCREDITED PROFESSIONAL STATISTICAN™, PStat® , 2012
  • Career Achievement Award, PhRMA
  • Named Outstanding Alumnus from Medical College of Virginia, Graduate School of Health Sciences, 1993

PROFESSIONAL EXPERIENCE

  • President Society for Clinical Trials
  • Pharmaceutical Research Manufacturers of America
    Chaired Biostatistics Committee
  • ICH: Member
    ICH Expert Working Group (E1) on Extent of Population Exposure
    ICH Expert Working Group (E9) on Biostatistics Guidelines for Clinical Trials
    ICH Expert Working Group (E10) on Choice of a Control Group.
  • World Health Organization
    Scientific Advisory Group for the International Clinical Trials Registry Project
  • Clinical Data Interchange Standards Consortium (CDISC)
    Chair and Member Board of Directors
  • National Library of Medicine
    Board of Regents Clinical Trial Working Group
  • Patient Centered Outcomes Research Institute
    Advisory Panel on Clinical Trials (current)
  • Frontier Science and Technology Research Institute
    Board of Directors (current)

SELECTED PUBLICATIONS

Rockhold, F., P. Nisen, and A. Freeman, Data Sharing at a Crossroads. New England Journal of Medicine, 2016. 375(12): p. 1115-1117.

Berlin, J.A., et al., Bumps and bridges on the road to responsible sharing of clinical trial data. Clin Trials, 2014. 11(1): p. 7-12.

Chan, A.W., et al., SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med, 2013. 158(3): p. 200-7.

Nisen, P. and F. Rockhold, Access to patient-level data from GlaxoSmithKline clinical trials. N Engl J Med, 2013. 369(5): p. 475-8.

Rockhold, F. and S. Bishop, Extracting The Value of Standards. Clinical Evaluation, 2012. 40(1).

Rockhold, F.W. and G.G. Enas, 10 Years with ICH E10: Choice of Control Groups. Pharm Stat, 2011. 10(5): p. 407-9.

Rockhold, F.W., A.J. Freeman, and C.A. Metz, Public disclosure of clinical trial results: a necessary step on the path to transparency and trust. Pharmaceutical Medicine, 2009. 23: p. 131+.

Ghersi, D., et al., Reporting the findings of clinical trials: a discussion paper. Bull World Health Organ, 2008. 86(6): p. 492-3.

Kush, R.D., et al., Electronic health records, medical research, and the Tower of Babel. N Engl J Med, 2008. 358(16): p. 1738-40.

Rockhold, F.W. and S.J. Ruberg, ICH-E9 reflections and considerations. Pharm Stat, 2008. 7(4): p. 233-5.

Metz, C.A., F. Rockhold, and A. Freeman, The GSK Clinical Study Results Database: Site Utilization Metrics for a Large Public Database. Drug Information Journal, 2008. 42(3): p. 247-252.

Rockhold, F.W. and R.L. Krall, Clinical trials registration. PLoS Med, 2006. 3(3): p. e157; author reply e167.

Rockhold, F.W., Requiring ‘independent’ statistical analyses for industry sponsored trials? Pharm Stat, 2006. 5(1): p. 5-6.

Rockhold, F.W. and R.L. Krall, Trial summaries on results databases and journal publication. Lancet, 2006. 367(9523): p. 1635-6.

DeMets, D., et al., Issues in regulatory guidelines for data monitoring committees. Clin Trials, 2004. 1(2): p. 162-9.

DeMets, D.L., et al., Liability issues for data monitoring committee members. Clin Trials, 2004. 1(6): p. 525-31.

Rockhold, F.W., Industry perspectives on ICH guidelines. Stat Med, 2002. 21(19): p. 949-57.

Lewis, J., et al., The impact of the international guideline entitled Statistical Principles for Clinical Trials (ICH E9). Stat Med, 2001. 20(17-18): p. 2549-60.

Rockhold, F.W., Strategic use of statistical thinking in drug development. Stat Med, 2000. 19(23): p. 3211-7.

Knatterud, G.L., et al., Guidelines for quality assurance in multicenter trials: a position paper. Control Clin Trials, 1998. 19(5): p. 477-93.

Rockhold, F.W. and M.R. Goldberg, An approach to the assessment of therapeutic drug interactions with fixed combination drug products. J Biopharm Stat, 1996. 6(3): p. 231-40.

Martin, L.F., et al., Continuous intravenous cimetidine decreases stress-related upper gastrointestinal hemorrhage without promoting pneumonia. Crit Care Med, 1993. 21(1): p. 19-30.

Rockhold, F.W. and G.G. Enas, Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations. Stat Med, 1993. 12(5-6): p. 471-9.

Rockhold, F.W., M.R. Goldberg, and W.L. Thompson, Beneficial effects of pinacidil on blood lipids: comparisons with prazosin and placebo in patients with hypertension. Pinacidil-Prazosin and Pinacidil-Placebo Research Groups, Lilly Research Laboratories. J Lab Clin Med, 1989. 114(6): p. 646-54.